Книга "Clinical Trial Design: Bayesian and Frequentist Adaptive Methods" рассматривает теории, методологии и проблемы дизайна клинических исследований, использующих статистические методы. В ней подробно описываются байесовские и частотные подходы к дизайну клинических исследований всех фаз, начиная с фазы I и заканчивая фазой IV. Книга также содержит обзор основ клинических исследований и сравнение байесовских и частотных статистических методов. Автор обращает внимание на практические вопросы и проблемы, возникающие в ходе клинических исследований, такие как анализ рисков и выгод для оценки токсичности и эффективности, а также дозирование лекарственных препаратов в комбинации. Книга содержит примеры клинических исследований, проводимых в медицинских центрах и фармацевтической индустрии, а также программное обеспечение, необходимое для проектирования клинических исследований. Книга предназначена для студентов магистратуры, а также для статистиков и биостатистиков в фармацевтической индустрии, а также для исследователей и практиков, занимающихся проектированием, проведением и мониторингом клинических исследований.
Электронная Книга «Clinical Trial Design. Bayesian and Frequentist Adaptive Methods» написана автором Guosheng Yin в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9781118183304
Описание книги от Guosheng Yin
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
